(195 days)
The Niobe® MNS with Navigant™ NWS is intended to navigate a magnet-tipped device through tissue to designated target sites in the right and left heart, coronary vasculature, neurovasculature and peripheral vasculature by orienting the device tip in a desired direction.
The Stereotaxis Niobe® MNS with Navigant™ NWS is an interventional workstation for the intravascular navigation of appropriately equipped, magnetically adapted, devices (e.g., catheters or guidewires) through tissue to designated target sites. The system uses computer-controlled permanent magnets for orienting the tip of a magnetic device. It is important to note that the system employs magnetic fields only to orient or steer the tip of a magnetic device.
The Niobe® MNS with Navigant™ NWS is an interventional workstation designed for the intravascular navigation of magnetic devices. The referenced document (K060967) does not contain a typical "acceptance criteria" table with specific quantitative benchmarks for performance metrics (like sensitivity, specificity, accuracy, etc.) that would typically be found for diagnostic or screening devices.
Instead, the submission primarily focuses on demonstrating substantial equivalence to predicate devices for expanded indications. The "performance data" section describes a clinical study that was used to support this claim, rather than detailing specific acceptance criteria the new device had to meet.
Here's an analysis based on the provided text, focusing on how the device "meets acceptance criteria" through substantial equivalence and the study cited:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, there isn't a conventional table of acceptance criteria with quantified performance metrics for the Niobe® MNS with Navigant™ NWS itself in this document. The "acceptance criteria" for this 510(k) submission appear to be centered around demonstrating that the device is substantially equivalent to predicate devices for its expanded indications, particularly given the new neurovasculature indication.
The primary "performance" that is reported in support of this is the safety and efficacy of magnetically guided devices when used in the neurovasculature, as demonstrated by a predicate device's clinical study.
| Acceptance Criterion (Implicit) | Reported Device Performance (via predicate device study) |
|---|---|
| Substantial Equivalence for Expanded Indications: The Niobe® MNS with Navigant™ NWS (with expanded indications) must be substantially equivalent to predicate devices for navigating compatible magnetic devices through tissue to designated target sites, particularly in the neurovasculature, without pre-shaping the tip prior to vessel insertion. | A Clinical Study was performed using the Stereotaxis Telstar® MNS and Cronus® Guidewires to demonstrate the safety and efficacy of magnetically guided devices when used in the neurovasculature. Stereotaxis states this clinical study is applicable to support substantial equivalence of the Niobe® MNS with Navigant™ NWS due to the predicate device successfully demonstrating clinical safety and efficacy of utilizing magnetic navigation with magnetic guidewires in the neurovasculature. |
| Technological Characteristics Equivalence: | |
| - Mechanical function and hardware remain the same as the existing Niobe® MNS with/Navigant™ NWS. | "The mechanical function and hardware of the existing Niobe® MNS with/Navigant™ NWS, will remain as is today." (Implicitly met by design). |
| - Intended use (to navigate compatible magnetic devices through tissue to designated target sites in any direction, without pre-shaping). | "They are intended to navigate compatible magnetic devices through tissue to designated target sites in any direction, without pre-shaping the tip prior to vessel insertion." (Stated as characteristic shared with predicate Telstar® MNS). |
| - Same intended use (navigating magnet-tipped devices in various vasculatures including heart, coronary, neuro, and peripheral). | "They have the same intended use, to navigate a magnet-tipped device through tissue to designated target sites in the right and left heart, coronary vasculature, neurovasculature and peripheral vasculature by orienting the device tip in a desired direction." (Stated as characteristic shared with predicate Telstar® MNS). |
| - Same operating field strength (0.15 Tesla). | "They have the same operating field strength, 0.15 Tesla." (Stated as characteristic shared with predicate Telstar® MNS). |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "A Clinical Study was performed using the Stereotaxis Telstar® MNS and Cronus® Guidewires to demonstrate the safety and efficacy of magnetically guided devices when used in the neurovasculature."
- Sample Size: The document does not specify the sample size used in this clinical study.
- Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. It only states it was a "Clinical Study."
3. Number of Experts and Qualifications
The document makes no mention of experts used to establish ground truth for a test set, nor their qualifications. The study described is a clinical study on a predicate device demonstrating safety and efficacy in actual procedure, not an evaluation of diagnostic accuracy requiring expert interpretation of outputs.
4. Adjudication Method
The document does not describe any adjudication method. This is consistent with the nature of the study, which evaluated the safety and efficacy of a medical procedure/device rather than the interpretation of data/images.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. The device in question (Niobe® MNS with Navigant™ NWS) is a steerable catheter control system for navigation, not a diagnostic imaging system that would typically involve human readers interpreting results with or without AI assistance.
6. Standalone (Algorithm Only) Performance
The concept of "standalone performance" (algorithm only performance without human-in-the-loop) is not applicable or discussed in this context. The Niobe® MNS with Navigant™ NWS is an interventional workstation that requires a human operator (interventional cardiologist/radiologist) to direct the navigation based on real-time imaging and clinical judgment. It does not operate as a standalone "algorithm" in the way a diagnostic AI might.
7. Type of Ground Truth Used
The "ground truth" for the clinical study referenced would have been clinical outcomes data related to the safety and efficacy of the procedure. This would include (but isn't explicitly detailed):
- Successful navigation to target sites.
- Absence of adverse events or complications.
- Achievement of the therapeutic goal for which the navigation was used.
This is inferred from the description "demonstrate the safety and efficacy of magnetically guided devices when used in the neurovasculature."
8. Sample Size for the Training Set
The document does not refer to a "training set" in the context of an AI/algorithm development. The "performance data" section refers to a clinical study of a predicate device, which would be an evaluation or validation study for that device, not a training set for an AI.
9. How Ground Truth for Training Set Was Established
As no training set (in the AI sense) is mentioned, there is no information on how its ground truth would have been established. The clinical study for the predicate device used real-world patient outcomes as its "truth" for evaluation.
§ 870.1290 Steerable catheter control system.
(a)
Identification. A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter.(b)
Classification. Class II (performance standards).